NCT00563303

Brief Summary

Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 23, 2010

Status Verified

April 1, 2010

Enrollment Period

Same day

First QC Date

September 26, 2006

Last Update Submit

April 20, 2010

Conditions

Polytraumatism

Outcome Measures

Primary Outcomes (1)

  • Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria

    28 days

Secondary Outcomes (2)

  • Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.

    28 days

  • Incidence of nosocomial pneumopathy

    Day 8

Study Arms (2)

H

EXPERIMENTAL

Hydrocortisone

Drug: hydrocortisone

P

PLACEBO COMPARATOR

Treatment by NaCl (placebo)

Drug: NaCl

Interventions

hydrocortisoneDRUG

200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6

H
NaClDRUG

48mL from Day 1 to Day 6

P

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age superior of 15 years
  • Hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk)
  • SISS score more than 15
  • Intubation for more than 48 hours.
  • Agreement of a family member
  • Patient with insurance

You may not qualify if:

  • History of corticothérapies within 6 months
  • History of adrenocortical insufficiency.
  • Treatment by immunosuppressor
  • Immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Bordeaux

Bordeaux, France

Location

CHU Morvan de Brest

Brest, 29609, France

Location

CHU Caen

Caen, France

Location

CH La Roche Sur Yon

La Roche-sur-Yon, France

Location

Hôtel Dieu

Nantes, 44093, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

CHU Trousseau

Tours, 37044, France

Location

Related Publications (3)

  • Le Bras M, Roquilly A, Deckert V, Langhi C, Feuillet F, Sebille V, Mahe PJ, Bach K, Masson D, Lagrost L, Costet P, Asehnoune K, Cariou B. Plasma PCSK9 is a late biomarker of severity in patients with severe trauma injury. J Clin Endocrinol Metab. 2013 Apr;98(4):E732-6. doi: 10.1210/jc.2012-4236. Epub 2013 Feb 28.

    PMID: 23450051DERIVED

  • Asehnoune K, Mahe PJ, Seguin P, Jaber S, Jung B, Guitton C, Chatel-Josse N, Subileau A, Tellier AC, Masson F, Renard B, Malledant Y, Lejus C, Volteau C, Sebille V, Roquilly A. Etomidate increases susceptibility to pneumonia in trauma patients. Intensive Care Med. 2012 Oct;38(10):1673-82. doi: 10.1007/s00134-012-2619-8. Epub 2012 Jul 10.

    PMID: 22777514DERIVED

  • Roquilly A, Mahe PJ, Seguin P, Guitton C, Floch H, Tellier AC, Merson L, Renard B, Malledant Y, Flet L, Sebille V, Volteau C, Masson D, Nguyen JM, Lejus C, Asehnoune K. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study. JAMA. 2011 Mar 23;305(12):1201-9. doi: 10.1001/jama.2011.360.

    PMID: 21427372DERIVED

MeSH Terms

Conditions

Multiple Trauma

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Mahe Joachim, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2006

First Posted

November 26, 2007

Study Start

November 1, 2006

Primary Completion

November 1, 2006

Study Completion

July 1, 2009

Last Updated

April 23, 2010

Record last verified: 2010-04

Locations

FR(7)